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Responsible for formulation design and development of clinical development candidates
Serve as drug product Project Leader to program teams for programs from early development through registration
Choose, oversee and manage CROs and CDMOs to ensure timely execution of high-quality deliverables in accordance with safety and compliance requirements and regulatory commitments
Interface on the establishment of product specifications, applying stage-appropriate and risk based approach
Provide input on program development strategies, budgets, and timelines to ensure that both technical and business requirements are achieved
Build and maintain strong working relationships with relevant internal Development and Discovery functions to effectively support on-going programs
CMC reviewer for formulation and drug product regulatory submissions
Requirements
MS with 8+ years or PhD with 5+ years of industrial experience
Extensive experience in compound profiling, formulation design, process development, and analytical characterization of small molecules
Knowledge of cGMP compliance, FDA and ICH guidelines and other regulatory requirements
Excellent management and interpersonal skills coupled with goal-oriented personality
Excellent communication, problem-solving skills
Good written and oral communication skills in English